BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 2

    MDR report key: 4987913 · Received August 10, 2015

    Report

    Report Number
    3007082252-2015-00008
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTED INJURIES ASSOCIATED WITH THIS INCIDENT. DURING A SCHEDULED PREVENTATIVE MAINTENANCE THE SERVICE TECHNICIAN NOTICED THAT THE ULTRASONIC FUNCTION WAS NOT WORKING. THE REPORTED SYMPTOM WAS ATTRIBUTED TO A SHORT OF Q1, Q2, AND Q5, MOSFET SWITCHES FOUND ON THE ULTRASONIC GENERATOR (500 W) BOARD, (B)(4), WHICH CAUSED THE FUSE TO OPEN, RENDERING THE BOARD INOPERABLE. THE LOSS OF THE ULTRASONIC GENERATOR DOES NOT, OF AND BY ITSELF, RESULT IN AN ENDOSCOPIC HIGH LEVEL DISINFECTION PROCESS FAILURE THAT DOES NOT RENDER A MICROBIOLOGICALLY SAFE PRODUCT OR PRESENT ANY ADDITIONAL RISKS FOR REUSE GIVEN THE NATURE OF THE PRE-CLEANING LABELING INSTRUCTIONS AND HIGH-LEVEL DISINFECTION. GIVEN THE NATURE OF ENDOSCOPE PRE-PROCESSING AND HIGH-LEVEL DISINFECTION BASED ON SGNA GUIDELINES, EITHER THE PRESENCE OR ABSENCE OF ULTRASONICS SHOULD STILL RESULT IS AN ENDOSCOPE THAT HAS HAD ITS BIOBURDEN REDUCED TO AN ACCEPTABLE LEVEL. IT IS CONCLUDED THAT THERE IS NO REASONABLE LIKELIHOOD THAT AN ENDOSCOPE PROCESSED IN THE ABSENCE OF THE ULTRASOUND WILL PRESENT ANY ADDITIONAL RISKS. ADDITIONALLY, THE CUSTOM ULTRASONICS SERVICE REPRESENTATIVE SERVICING THE DEVICE INSTALLED AN ULTRASONICS FEEDBACK ALERT SYSTEM ENHANCEMENT. THE UFAS ENHANCEMENT DETECTS THE ULTRASONICS FUNCTION OF THE SYSTEM 83 PLUSWASHER/DISINFECTOR DURING THE WASH AND RINSE PHASES OF A REPROCESSING CYCLE AND ALERTS THE USER OF STATUS BY A LED INDICATOR..

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE , IT WAS DISCOVERED THAT THE ULTRASONICS WERE NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522087 SYSTEM 83 PLUS 2 ENDOSCOPE WASHER - DISINFECTOR FEB CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 2

    Patients

    Seq Age Sex Outcome Treatment
    1